Phase III Study of Concurrent Radiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma (ESO-Shanghai 15)

Обзор

So far, there is no specific clinical guideline for elderly patients (\>75 yr) with esophageal squamous cell carcinoma (ESCC). Patients with locally advanced ESCC were enrolled and randomly assigned to either definitive radiotherapy group (61.2Gy/34Fx） or the chemoradiotherapy group (50.4Gy/28Fx；Paclitaxel plus carboplatin). The primary end point was 3-year overall survival (OS). The second end points included life quality, radiation side effects and 3-yr cancer specific survival.

Подробное описание

Up to now, definitive radiotherapy was major treatment plan for elderly ESCC patients. However, whether elective elderly patients can obtain survival benefits through chemoradiotherapy is not clear. Thus we design the clinical trail to answer the question.

Three hundred and twenty elderly patients with ESCC would be recruited. There are two stratification factors including 80 years old and lymph node metastasis. The patients in the chemoradiotherapy group were treated with paclitaxel (45mg/m2) and carboplatin (AUC=2) one cycle per week for five cycles.The primary end point was 3-year overall survival (OS). The second end points included life quality, radiation side effects and 3-yr cancer specific survival. The life quality questionnaire included QlQ-C30 and OES-18.

Вмешательства

• Препарат Paclitaxel plus carboplatin
  Paclitaxel （45mg/m2) plus carboplatin (AUC=2); five cycles; qw
• Лучевая терапия radiotherapy
  Different radiotherapy dose in different groups.

Первичные конечные точки

• overall survival difference of definitive radiotherapy and chemoradiotherapy groups [Срок оценки: 3-year]

Вторичные конечные точки (3)

• difference of quality of life between different groups [Срок оценки: the period of treatment within 7 weeks and follow up time with an average of 3months]
• radiation side effects [Срок оценки: acute side effects within 3 months, late side effects for 3 months later]
• cancer specific survival [Срок оценки: 3-year]

Критерии участия

Критерии включения

• Indicates no limit on eligibility based on the sex of participants
• The 76 years old for the minimum age a potential participant must meet to be eligible for the clinical study.
• Esophageal squamous cell carcinoma confirmed by pathology
• No radiotherapy, chemotherapy or other treatments prior to enrollment
• Local advanced esophageal squamous cell carcinoma (T2-4N0-1M0-1a, TxN1M0-1a, TxNxM1a, TxNxM1b (M1b only for supraclavicular lymph node metastasis) (AJCC 6th)
• Use of an effective contraceptive for adults to prevent pregnancy
• No severely abnormal hematopoietic, cardiac, pulmonary, renal, or hepatic function
• No immunodeficiency
• ECOG 0-1.
• Life expectancy of more than 3 months.

Критерии исключения

• Total radiotherapy dose cannot reach 61.2Gy/34Fx
• Esophageal perforation, or hematemesis
• History of radiotherapy or chemotherapy for esophageal cancer
• History of surgery within 28 days before Day 1
• History of prior malignancies (other than skin basal cell carcinoma or cervical carcinoma in situ with a disease-free survival of at least 3 years)
• Participation in other interventional clinical trials within 30 days
• Pregnant or breast-feeding women or fertile patients
• Drug addiction,
• alcoholism or AIDS
• Uncontrolled seizures or psychiatric disorders

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 3 центра

• Jiangsu Cancer Hospital — Нанкин
• Huadong Hospital — Шанхай
• Fudan Universtiy Shanghai Cancer Center — Шанхай

Идентификаторы

NCT: NCT04519905 · ESO-Shanghai15

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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